Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-320, 18VAC110-20-540, 18VAC110-20-550, 18VAC110-20-555).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information:

September 26, 2017 - 9:05 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2, Richmond, VA 23233

Public Comment Deadline: November 3, 2017.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system. The specific authority of the board to regulate the practice of pharmacy is found in § 54.1-3307 of the Code of Virginia.

Purpose: Granting the pharmacist authority to dispense a quantity of a Schedule VI substance greater than the amount initially noted on the prescription would benefit patients and prescribers with greater flexibility and improved medication adherence. A pharmacist would be able to use professional judgment about whether to dispense in conformity with the prescribed amount and dosage. Such flexibility will enable a pharmacist to more easily synchronize the patient's medications, allowing prescriptions to run out on the same date and reducing the patient's visits to the pharmacy.

Allowing the use of electronic devices for emergency and stat-drug boxes is becoming a standard for acute long-term care facilities, as such devices can minimize diversion and direct access for staff to the correct location for first dose administration.

Both changes are reasonable accommodations in the practice of pharmacy that will benefit the health and safety of patients without jeopardizing the integrity and efficacy of the drug supply in the Commonwealth.

Substance: In response to two petitions for rulemaking, the proposed amendments:

1) Amend 18VAC110-20-320 to authorize a pharmacist, when deemed appropriate in the pharmacist's professional judgement and upon request by the patient, to dispense a quantity of a Schedule VI drug, excluding psychotherapeutic agents, anxiolytics, sedatives, or hypnotics or drugs of concern, in excess of the specific quantity prescribed for a dispensing, not to exceed the total amount authorized in refills; and

2) Amend 18VAC110-20-540, 18VAC110-20-550, and 18VAC110-20-555 to specifically authorize the use of an automated dispensing device in a nursing home for obtaining drugs that would be stocked in a stat-drug box or an emergency kit.

Issues: The primary advantage to the public is more flexibility in obtaining Schedule VI drugs. If a consumer is prescribed a drug for a chronic condition and has a certain number of refills on the prescription, the patient may prefer to get the total quantity dispensed rather than having to come back or reorder when the drug is due to be refilled. The advantage to residents of nursing homes would be drugs used for nonroutine administration would be more readily available through an automated dispensing device. There are no disadvantages to the public. There are no advantages or disadvantages to the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. In response to a petition for rulemaking,¹ the Board of Pharmacy proposes to allow a pharmacist to dispense a quantity of certain Schedule VI drugs greater than the face amount prescribed, up to the total amount authorized in refills. In response to a separate petition for rulemaking,² the Board proposes to allow the use of automated drug dispensing devices in nursing homes in lieu of manual emergency drug kits and stat-drug boxes.

Result of Analysis. Benefits likely outweigh costs for all proposed changes.

Estimated Economic Impact. Current regulation only allows pharmacists to dispense Schedule VI medication at, or less than, the quantity for which a prescription is written. As requested in a petition for rulemaking, the Board now proposes to authorize pharmacists to dispense any Schedule VI drugs not specifically excluded by this proposed regulation³ in a quantity in excess of the face amount prescribed and not exceeding the total quantity authorized in refills. Under this proposed rule, a pharmacist will be able to dispense Schedule VI medications in these larger allowable quantities if 1) a patient has requested that his medication be dispensed in a larger quantity than is written on his prescription and 2) it is deemed appropriate by the pharmacist using his professional judgement. Since Schedule VI drugs are deemed at low risk of abuse, and the Schedule VI drugs that are possibly more dangerous are excluded from the proposed rule change, no entity is likely to be harmed by this proposed change. Consumers are likely to benefit from this change as it allows them greater flexibility to manage the timing of medication purchases.

Current regulation requires that nursing homes have a controlled substances registration (if they do not have an in-house pharmacy) in order to use an automated drug dispensing system in all instances. This rule is more stringent than Drug Enforcement Administration (DEA) rules, which allow nursing homes to use automated drug dispensing systems to dispense emergency or first dose medications without having to obtain a controlled substances registration. As requested in a petition for rulemaking, the Board now proposes to also allow the use of automated drug dispensing systems, that are stocked exclusively with drugs that would be stocked in a stat-drug box or an emergency drug kit, to dispense emergency or first dose medications without a controlled substances registration so long as access to the automated drug dispensing systems are restricted to licensed nurses, pharmacists, prescribers and registered medication technicians. The Board also proposes to allow automated drug dispensing systems to be stocked, with drugs that would be stocked in a stat-drug box, in quantities determined by provider pharmacies rather than in quantities specified by this regulation for stat-drug boxes. No entity is likely to be harmed by these changes. Both nursing homes and their patients are likely to benefit from having added flexibility as to how drugs that may be necessary to maintain the health of patients, in the case of an emergency or after hours, are stored and dispensed.

Businesses and Entities Affected. These proposed regulatory changes will affect pharmacies that dispense Schedule VI drugs, provider pharmacies and nursing homes that have automated dispensing devices. Board staff reports that there are 1,852 pharmacies that are permitted by the Board to dispense medication in Virginia.

Localities Particularly Affected. No locality is likely to be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. These proposed regulatory changes are unlikely to affect employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Alternative Method that Minimizes Adverse Impact. No small businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Adverse Impacts:

Businesses. No businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Localities. Localities in the Commonwealth are unlikely to see any adverse impacts on account of these proposed regulatory changes.

Other Entities. No other entities are likely to be adversely affected by these proposed changes.

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¹ This petition can be found here: http://townhall.virginia.gov/l/viewpetition.cfm?petitionid=245 .

² This petition can be found here: http://townhall.virginia.gov/l/viewpetition.cfm?petitionid=247 .

³ This new proposed rule will not apply to Schedule VI drugs that are classified by the American Hospital Formulary Service as psychotherapeutic agents, anxiolytics, sedatives or hypnotics. Anxiolytics are medications that inhibit anxiety in a patient.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget on proposed amendments.

Summary:

In response to two separate petitions for rulemaking, the proposed amendments (i) permit a pharmacist, when deemed appropriate in the pharmacist's professional judgement and upon request by the patient, to dispense a quantity of a Schedule VI drug, excluding certain drugs, in excess of the specific quantity prescribed for a dispensing, not to exceed the total amount authorized in refills and (ii) authorize the use of automated dispensing devices in nursing homes in lieu of manual emergency drug kits and stat-drug boxes.

18VAC110-20-320. Refilling of Schedule Schedules III through VI prescriptions.

A. A prescription for a drug listed in Schedule III, IV, or V shall not be dispensed or refilled more than six months after the date on which such prescription was issued, and no such prescription authorized to be filled may be refilled more than five times.

1. Each refilling of a prescription shall be entered on the back of the prescription or on another record in accordance with § 54.1-3412 and 18VAC110-20-255, initialed and dated by the pharmacist as of the date of dispensing. If the pharmacist merely initials and dates the prescription, it shall be presumed that the entire quantity ordered was dispensed.

2. The partial dispensing of a prescription for a drug listed in Schedule III, IV, or V is permissible, provided that:

a. Each partial dispensing is recorded in the same manner as a refilling;

b. The total quantity of drug dispensed in all partial dispensing does not exceed the total quantity prescribed; and

c. No dispensing occurs after six months after the date on which the prescription order was issued.

B. A prescription for a drug listed in Schedule VI shall may be refilled only as expressly authorized by the practitioner. If no such authorization is given, the prescription shall not be refilled, except as provided in § 54.1-3410 C or subdivision 4 of § 54.1-3411 of the Code of Virginia. Except for drugs classified by the American Hospital Formulary Service as psychotherapeutic agents, anxiolytics, sedatives, or hypnotics or for drugs of concern as defined in § 54.1-2519 of the Code of Virginia, a pharmacist, using professional judgment and upon request by the patient, may refill a drug listed in Schedule VI with any quantity, up to the total amount authorized, taking all refills into consideration.

A prescription for a Schedule VI drug or device shall not be dispensed or refilled more than one year after the date on which it was issued unless the prescriber specifically authorizes dispensing or refilling for a longer period of time not to exceed two years.

C. As an alternative to all manual recordkeeping requirements provided for in subsections A and B of this section, an automated data processing system as provided in 18VAC110-20-250 may be used for the storage and retrieval of all or part of dispensing information for prescription drugs dispensed.

D. The timing of dispensing an authorized refill of a prescription shall be within reasonable conformity with the directions for use as indicated by the practitioner; if directions have not been provided, then any authorized refills may only be dispensed in reasonable conformity with the recommended dosage and with the exercise of sound professional judgment. An authorized refill may be dispensed early provided the pharmacist documents a valid reason for the necessity of the early refill.

18VAC110-20-540. Emergency drug kit.

A. The pharmacist providing services may prepare an emergency kit for a long-term care facility in which access to the kit is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the kit and only under the following conditions:

1. The contents of the emergency kit shall be of such a nature that the absence of the drugs would threaten the survival of the patients.

2. The contents of the kit or an automated drug dispensing system, as provided in subsection B of this section, shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the institutions and shall be limited to drugs for administration by injection or inhalation only, except that Nitroglycerin SL and diazepam rectal gel may be included.

3. The kit is sealed in such a manner that it will preclude any possible loss of the drug.

a. The dispensing pharmacy must have a method of sealing such kits so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication, resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box or kit and maintain the record until such time as the seal is replaced.

c. In lieu of seals, a kit with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.

4. The kit shall have a form to be filled out upon opening the kit and removing contents to write the name of the person opening the kit, the date, time and name and quantity of items removed. The opened kit is maintained under secure conditions and returned to the pharmacy within 72 hours for replenishing.

5. Any drug used from the kit shall be covered by a prescription, signed by the prescriber, when legally required, within 72 hours.

B. Drugs that would be stocked in an emergency kit, pursuant to this section, may be stocked in an automated drug dispensing system in a nursing home in accordance with 18VAC110-20-555.

18VAC110-20-550. Stat-drug box.

A. An additional drug box called a stat-drug box may be prepared by a pharmacy to provide for initiating therapy prior to the receipt of ordered drugs from the pharmacy. Access to the stat-drug box is restricted to a licensed nurse, pharmacist, or prescriber and only these licensed individuals may administer a drug taken from the stat-drug box. Additionally, a valid prescription or lawful order of a prescriber must exist prior to the removal of any drug from the stat-drug box. A stat-drug box shall be subject to the following conditions:

1. The box is sealed in such a manner that will preclude the loss of drugs.

a. The dispensing pharmacy must have a method of sealing such boxes so that once the seal is broken, it cannot be reasonably resealed without the breach being detected.

b. If a seal is used, it shall have a unique numeric or alphanumeric identifier to preclude replication or resealing, or both. The pharmacy shall maintain a record of the seal identifiers when placed on a box and maintain the record until such time as the seal is replaced.

c. In lieu of seals, a box with a built-in mechanism preventing resealing or relocking once opened except by the provider pharmacy is also acceptable.

2. The box shall have a form to be filled out upon opening the box and removing contents to write the name of the person opening the box, the date, the time, and the name and quantity of item(s) items removed. When the stat-drug box has been opened, it is returned to the pharmacy.

3. There shall be a listing of the contents of the box maintained in the pharmacy and also attached to the box in the facility. This same listing shall become a part of the policy and procedure manual of the facility served by the pharmacy.

4. The drug listing on the box shall bear an expiration date for the box. The expiration date shall be the day on which the first drug in the box will expire.

5. The contents of the box shall be limited to those drugs in which a delay in initiating therapy may result in harm to the patient.

a. The listing of drugs contained in the stat-drug box shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the long-term care facility.

b. The stat-drug box shall contain no more than 20 solid dosage units per schedule of Schedule Schedules II through V drugs except that one unit of liquid, not to exceed 30 ml, may be substituted for a solid dosage unit. If the unit of a liquid that may contain more than one dose is removed from the stat-drug box pursuant to a patient order, the remainder shall be stored with that patient's other drugs, may be used for subsequent doses administered to that patient, and shall not be administered to any other patient.

B. Drugs that would be stocked in a stat-drug box, pursuant to this section, may be stocked in an automated drug dispensing system in a nursing home in accordance with 18VAC110-20-555, except that the quantity of drugs in Schedules II through V stocked in the system shall be determined by the provider pharmacist in consultation with the medical and nursing staff of the nursing home.

18VAC110-20-555. Use of automated dispensing devices.

Nursing homes licensed pursuant to Chapter 5 (§ 32.1-123 et seq.) of Title 32.1 of the Code of Virginia may use automated drug dispensing systems, as defined in § 54.1-3401 of the Code of Virginia, upon meeting the following conditions:

1. Drugs placed in an automated drug dispensing system in a nursing home shall be under the control of the pharmacy providing services to the nursing home, the pharmacy shall have on-line online communication with and control of the automated drug dispensing system, and access to any drug for a patient shall be controlled by the pharmacy.

2. A nursing home without an in-house pharmacy shall obtain a controlled substances registration prior to using an automated dispensing system, unless the system is exclusively stocked with drugs that would be kept in a stat-drug box pursuant to 18VAC110-20-550 or an emergency drug kit pursuant to 18VAC110-20-540 and are solely administered for stat or emergency administration.

3. For facilities not required to obtain a controlled substance registration, access to the automated dispensing device shall be restricted to a licensed nurse, pharmacist, or prescriber, or a registered pharmacy technician for the purpose of stocking or reloading.

4. Removal of drugs from any automated drug dispensing system for administration to patients can only be made pursuant to a valid prescription or lawful order of a prescriber under the following conditions:

a. A drug, including a drug that would be stocked in a stat-drug box pursuant to subsection B of 18VAC110-20-550, may not be administered to a patient from an automated dispensing device until a pharmacist has reviewed the prescription order and electronically authorized the access of that drug for that particular patient in accordance with the order.

b. The PIC of the provider pharmacy shall ensure that a pharmacist who has on-line online access to the system is available at all times to review a prescription order as needed and authorize administering pursuant to the order reviewed.

c. Drugs that would be stocked in an emergency drug kit pursuant to 18VAC110-20-540 may be accessed prior to receiving electronic authorization from the pharmacist provided that the absence of the drugs would threaten the survival of the patients.

d. Automated dispensing devices shall be capable of producing a hard-copy record of distribution that shall show patient name, drug name and strength, dose withdrawn, dose to be administered, date and time of withdrawal from the device, and identity of person withdrawing the drug.

4. 5. Drugs placed in automated dispensing devices shall be in the manufacturer's sealed original unit dose or unit-of-use packaging or in repackaged unit-dose containers in compliance with the requirements of 18VAC110-20-355 relating to repackaging, labeling, and records.

5. 6. Prior to the removal of drugs from the pharmacy, a delivery record shall be generated for all drugs to be placed in an automated dispensing device, which shall include the date; drug name, dosage form, and strength; quantity; nursing home; a unique identifier for the specific device receiving drugs; and initials of the pharmacist checking the order of drugs to be removed from the pharmacy and the records of distribution for accuracy.

6. 7. At the direction of the PIC, drugs may be loaded in the device by a pharmacist or a pharmacy technician adequately trained in the proper loading of the system.

7. 8. At the time of loading, the delivery record for all Schedule Schedules II through VI drugs shall be signed by a nurse or other person authorized to administer drugs from that specific device, and the record returned to the pharmacy.

8. 9. At the time of loading any Schedule Schedules II through V drug, the person loading will verify that the count of that drug in the automated dispensing device is correct. Any discrepancy noted shall be recorded on the delivery record and immediately reported to the PIC, who shall be responsible for reconciliation of the discrepancy or the proper reporting of a loss.

9. 10. The PIC of the provider pharmacy or his designee shall conduct at least a monthly audit to review distribution and administration of Schedule Schedules II through V drugs from each automated dispensing device as follows:

a. The audit shall reconcile records of all quantities of Schedule Schedules II through V drugs dispensed from the pharmacy with records of all quantities loaded into each device to detect whether any drugs recorded as removed from the pharmacy were diverted rather than being placed in the proper device.

b. A discrepancy report shall be generated for each discrepancy in the count of a drug on hand in the device. Each such report shall be resolved by the PIC or his designee within 72 hours of the time the discrepancy was discovered or, if determined to be a theft or an unusual loss of drugs, shall be immediately reported to the board in accordance with § 54.1-3404 E of the Drug Control Act.

c. The audit shall include a review of a sample of administration records from each device per month for possible diversion by fraudulent charting. A sample shall include all Schedule Schedules II through V drugs administered for a time period of not less than 24 consecutive hours during the audit period.

d. The audit shall include a check of medical records to ensure that a valid order exists for a random sample of doses recorded as administered.

e. The audit shall also check for compliance with written procedures for security and use of the automated dispensing devices, accuracy of distribution from the device, and proper recordkeeping.

f. The hard copy distribution and administration records printed out and reviewed in the audit shall be initialed and dated by the person conducting the audit. If nonpharmacist personnel conduct the audit, a pharmacist shall review the record and shall initial and date the record.

10. 11. Automated dispensing devices shall be inspected monthly by pharmacy personnel to verify proper storage, proper location of drugs within the device, expiration dates, the security of drugs and validity of access codes.

11. 12. Personnel allowed access to an automated dispensing device shall have a specific access code which records the identity of the person accessing the device.

12. 13. The PIC of the pharmacy providing services to the nursing home shall establish, maintain, and assure compliance with written policy and procedure for the accurate stocking and proper storage of drugs in the automated drug dispensing system, accountability for and security of all drugs maintained in the automated drug dispensing system, preventing unauthorized access to the system, tracking access to the system, complying with federal and state regulations related to the storage and dispensing of controlled substances, maintaining patient confidentiality, maintaining required records, and assuring compliance with the requirements of this chapter. The manual shall be capable of being accessed at both the pharmacy and the nursing home.

13. 14. All records required by this section shall be filed in chronological order from date of issue and maintained for a period of not less than two years. Records shall be maintained at the address of the pharmacy providing services to the nursing home except:

a. Manual Schedule VI distribution records may be maintained in offsite storage or electronically as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

b. Distribution and delivery records and required signatures may be generated or maintained electronically provided:

(1) The system being used has the capability of recording an electronic signature that is a unique identifier and restricted to the individual required to initial or sign the record.

(2) The records are maintained in a read-only format that cannot be altered after the information is recorded.

(3) The system used is capable of producing a hard-copy printout of the records upon request.

c. Schedule II-V Schedules II through V distribution and delivery records may only be stored offsite or electronically as described in subdivisions 13 a and 13 b of this section if authorized by DEA or in federal law or regulation.

d. Hard-copy distribution and administration records that are printed and reviewed in conducting required audits may be maintained off site offsite or electronically provided they can be readily retrieved upon request; provided they are maintained in a read-only format that does not allow alteration of the records; and provided a separate log is maintained for a period of two years showing dates of audit and review, the identity of the automated dispensing device being audited, the time period covered by the audit and review, and the initials of all reviewers.